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A multi-center clinical study of the staged pattern differentiation of Qinghua and stasis removal preparations for the treatment of IgA nephropathy

A multi-center clinical study of the staged pattern differentiation of Qinghua and stasis removal preparations for the treatment of IgA nephropathy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094993
Enrollment
Unknown
Registered
2024-12-31
Start date
2023-06-19
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA nephropathy

Interventions

Group A1 (patients with CKD1-2 stage, proteinuria less than 2.5 g, and IgA nephropathy with lung and spleen qi deficiency and water, dampness and blood stasis):Drug dosage and drug regimen: losartan p
Treatment course: 24 weeks, and the clinical efficacy of patients will be evaluated every 2 months.
Group B1 (patients with CKD1-2 stage, proteinuria less than 2.5 grams, and IgA nephropathy with lung, spleen, qi and spleen qi deficiency and water, dampness and blood stasis):Drug dosage and medicati
Group A2 (patients with CKD3 stage, proteinuria less than 2.5 g, and IgA nephropathy with liver and kidney yin deficiency and damp blood stasis):Drug dosage and medication regimen Losartan potassium 5
Group B2 (patients with CKD3 stage, proteinuria less than 2.5 g, and IgA nephropathy with liver and kidney yin deficiency and damp blood stasis):Drug dosage and medication regimen Losartan potassium 5
Group A3 (patients with CKD stage 4-5, pathologically confirmed IgA nephropathy, and the syndrome type is spleen and kidney yang deficiency with cold, dampness and blood stasis):Drug dosage and medica

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Part I (1) Age 18~75 years old, gender and ethnicity are not limited; (2) Pathologic diagnosis of IgA nephropathy; (3) Renal function: stage 1-2; (4) TCM syndrome differentiation is consistent with the syndrome of lung and spleen qi deficiency, and both water and dampness and stasis; (5) Pathological indicators: Lee's grade II or above, or Pathological changes like segmental or glomerular sclerosis, renal tubular atrophy, and interstitial fibers can be seen. (6) 24-hour urine protein quantification = 2.5g. Part II (1) Age 18~75 years old, gender and ethnicity are not limited; (2) Pathologic diagnosis of IgA nephropathy; (3) Renal function: stage 3; (4) TCM syndrome differentiation is consistent with liver and kidney yin deficiency syndrome, dampness and heat, and blood stasis; (5) Pathological indicators: Lee's grade II or above, or pathological segmental or glomerular sclerosis, renal tubular atrophy, and interstitial fibers can be seen Pathological changes predominantly lesions. (6) 24-hour urine protein quantification = 2.5g. Part III (1) Age 18~75 years old, gender and ethnicity are not limited; (2) Pathologic diagnosis of IgA nephropathy; (3) Renal function: stage 4-5; (4) The syndrome differentiation of traditional Chinese medicine is consistent with the spleen and kidney yang deficiency syndrome, which is both cold and damp and stasis; (5) Pathological indicators: Lee's grade II or above, or pathological segmental or glomerular sclerosis, renal tubular atrophy, and interstitial fibers can be seen Pathological changes predominantly lesions.

Exclusion criteria

Exclusion criteria: (1) Received immunosuppressants and cytotoxic drugs in the past 3 months > 4 weeks; (2) Have received glucocorticoids (prednisone or prednisolone) at a dose of 20mg/d >> for 4 weeks in the past 3 months; (3) Patients with acute or rapidly progressive nephritis and patients with acute progressive IgA nephropathy; (4) Patients with active hepatitis B and abnormal aminotransferases in continuous liver function tests; (5) Patients with malignant tumors or history of malignant tumors, HIV infection, psychiatric disorders, acute central nervous system diseases, severe gastrointestinal diseases and contraindications to the use of glucocorticoids; (6) Patients with abnormal glucose metabolism and fasting blood glucose > 6.2mmol/L; (7) Pregnant or lactating women; (8) Investigators who are undergoing other clinical trials; (9) Patients with life-threatening complications, such as severe infection or serious diseases and dysfunction of other organs. (10) IgA disease caused by secondary factors such as allergic purpura nephritis, chronic alcoholic liver disease, ankylosing spondylitis, psoriasis, lupus nephritis, etc.;Patients with serious primary diseases such as heart, brain, liver and hematopoietic system;patients with mental illness;patients allergy to the test drug or intolerant of known adverse reactions.

Design outcomes

Primary

MeasureTime frame
24-hour urinary protein quantification;

Countries

China

Contacts

Public ContactYang Xuejun

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

yangxuejun@shutcm.edu.cn+86 130 0322 6766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026